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RAPITIL 2.0% W/V EYE DROPS SOLUTION

Active substance(s): NEDOCROMIL SODIUM / NEDOCROMIL SODIUM

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PACKAGE LEAFLET:
INFORMATION FOR THE USER

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Read all of this leaflet carefully before you start using
this medicine
• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your doctor or
pharmacist.
• This medicine has been prescribed for you. Do not pass it
on to others. It may harm them, even if their symptoms are
the same as yours.
• If any of the side effects gets serious, or if you notice any
side effects not listed in this leaflet, please tell your doctor
or pharmacist. See section 4.
In this leaflet:
1. What Rapitil Eye Drops are and what they are used for
2. Before you use Rapitil Eye Drops
3. How to use Rapitil Eye Drops
4. Possible side effects
5. How to store Rapitil Eye Drops
6. Further information
1. What Rapitil Eye Drops are and what they
are used for
What Rapitil Eye Drops are
Rapitil 2% Eye Drops (called Rapitil Eye Drops in this leaflet)
contain a medicine called nedocromil sodium. This belongs to
a group of medicines called anti-allergics.
How Rapitil Eye Drops work
It works by stopping the release of the natural substances in
your eyes that can lead to an allergic reaction.

What Rapitil Eye Drops can be used for
Stopping, treating and relieving the symptoms of ‘allergic
conjunctivitis’ (inflammation of parts of the eye). Rapitil Eye
Drops can be used for three types of allergic conjunctivitis:
• ‘Perennial allergic conjunctivitis’ in adults only: This
type of allergy can happen at any time of the year and
is often caused by animal fur or house dust mites. Signs
include itchy, watery, red or inflamed eyes and puffy
eyelids.
• ‘Seasonal allergic conjunctivitis’ in adults and
children: This type of allergy, such as hay fever, can be
caused by different pollens in different seasons of the year.
Signs include itchy, watery, red or inflamed eyes and puffy
eyelids.
• ‘Vernal kerato conjunctivitis’ in adults and children:
This is a more severe type of allergy. Signs include bumps
inside the upper eyelid, sensitivity to light and severe
itching
2. Before you use Rapitil eye drops
Do not use this medicine and tell your doctor or
pharmacist if:
X You are allergic (hypersensitive) to nedocromil sodium, or
any of the other ingredients of Rapitil Eye Drops (listed in
Section 6 below).
Signs of an allergic reaction include: a rash, swallowing or
breathing problems, swelling of your lips, face, throat or
tongue or around the eyes.
Do not use this medicine if the above applies to you. If you
are not sure, talk to your doctor or pharmacist before using
Rapitil Eye Drops.
Take special care with Rapitil Eye Drops if:
You wear soft contact lenses. You should not wear soft
contact lenses while using these drops.
If you are not sure if this applies to you, talk to your doctor or
pharmacist before using Rapitil Eye Drops.
Pregnancy and breast-feeding
Talk to your doctor before using this medicine if you are
pregnant, might become pregnant or think you may be

pregnant.
If you are breast-feeding or planning to breast-feed, talk to
your doctor or pharmacist before taking or using any medicine.
Driving and using machines
Your eyesight may be affected after using this medicine. If this
happens, do not drive or use any tools or machines until you
can see clearly.
Important information about some of the ingredients of
Rapitil Eye Drops
Rapitil Eye Drops contain benzalkonium chloride. This may
cause your eyes to become irritated. It may also change the
colour of your contact lenses.
3. How to use Rapitil Eye Drops
Always use Rapitil Eye Drops exactly as your doctor or
pharmacist has told you. You should check with your doctor or
pharmacist if you are not sure.
Using this medicine
• If you wear hard or gas-permeable contact lenses, you
should take them out while you use the eye drops. You
should wait 15 minutes before you put the contact lenses
back in
• If you need to use more than one type of eye medicine,
the medicines must be used at least 5 minutes apart. Eye
ointments should be used last.
• If you feel the effect of your medicine is too weak or too
strong, do not change the dose yourself, but ask your
doctor or pharmacist
How to use this medicine
• Wash your hands
• Remove the cap from the
bottle
• Tilt your head back
• Squeeze one or two
drops inside the lower lid
without touching your eye

• Close your eye
• Wipe away any excess liquid from the eyes with a clean
tissue
• Always put the cap back on the bottle as soon as you have
used it
• Repeat in the other eye as needed
How much to use
Adults, Elderly and Children aged
6 years and over
Seasonal allergic conjunctivitis:
• One drop into each eye twice each day
• This can be increased to four times each day if needed
• Do not use for more than 12 weeks
Vernal kerato-conjunctivitis
• One drop into each eye four times each day
Adults and the Elderly only
Perennial allergic conjunctivitis:
• One drop into each eye twice each day
• This can be increased to four times each day if needed
• Use the drops regularly
Children under 6 years
This medicine is not recommended for children aged less than
6 years.
If you take more Rapitil Eye Drops than you should
If you use more Rapitil than you should, talk to your doctor or
go to a hospital straight away. Remember to take any medicine
that is left with you so the doctor knows what you have taken.
If you forget to use Rapitil Eye Drops
If you forget a dose, use your drops as soon as you remember.
However, if it is nearly time for your next dose, skip the missed
dose. Do not use a double dose to make up for a forgotten
dose.
If you stop using Rapitil Eye Drops
Keep using the eye drops for as long as your doctor or
pharmacist advises you. If you stop using Rapitil Eye drops too
early, your allergy symptoms may come back.
If you have any further questions on the use of this
product, ask your doctor or pharmacist.

4. Possible side effects
Like all medicines, Rapitil Eye Drops can cause side effects,
although not everybody gets them.
Stop using Rapitil Eye Drops and see a doctor as soon
as possible if:
• The itching, redness or swelling gets worse. You may be
allergic to these drops
Talk to your doctor or pharmacist if any of the side
effects gets serious or lasts longer than a few days, or
if you notice any side effects not listed in this leaflet:
Common (affects 1 to 10 people in a 100)
• Stinging or burning in your eyes or blurring of eyesight. This
should only last for a short time and occurs immediately
after using the eye drops
• Change in the way things taste
Uncommon (affects 1 to 10 people in a 1,000)
• Mild eye irritation
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or
nurse. This includes any possible side effects not listed in this
leaflet. You can also report side effects directly via the Yellow
Card Scheme at: www.mhra.gov.uk/yellowcard
By reporting side effects you can help provide more
information on the safety of this medicine.
5. How to store Rapitil Eye Drops
Keep this medicine in a safe place where children cannot see
or reach it.
Do not use Rapitil Eye Drops after the expiry date which is
stated on the label and carton. The expiry date refers to the
last day of that month.
Store below 25°C. Keep the bottle in the outer carton in order
to protect from light.
Rapitil Eye Drops are sterile when you buy them, so you must
not keep them for more than four weeks after opening the
bottle.
Medicines should not be disposed of via wastewater or
household waste.

Ask your pharmacist how to dispose of medicines no longer
required. These measures will help to protect the environment.
6. Further information
What Rapitil Eye Drops contain
• The solution contains 2% w/v of the active substance,
nedocromil sodium
• The other ingredients are disodium edetate, benzalkonium
chloride, sodium chloride and Water for injections
What Rapitil Eye Drops look like and contents of the pack
Rapitil Eye Drops are available as a clear yellow solution
supplied in a 3 ml or 5 ml plastic dropper bottle. Not all pack
sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Sanofi, One Onslow Street, Guildford, Surrey, GU1 4YS, UK
email: uk-medicalinformation@sanofi.com
Tel: 0845 372 7101
Manufacturer
Zentiva k.s.,
U Kabelovny 130
102 37 Prague 10,
Czech Republic.
This leaflet does not contain all the information about your
medicine. If you have any questions or are not sure about
anything, ask your doctor or pharmacist.
This leaflet was last revised in November 2016
© Sanofi, 1995 - 2016

ZV/571 34

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Source: Medicines and Healthcare Products Regulatory Agency

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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